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原文：
A transcatheter pulmonary valve for use in patients with dysfunctional right ventricular outflow tract (RVOT) conduits has shown a high rate of procedural success and encouraging Ball Valves
short-term function, despite some concern about reinterventions for stent fractures. The findings, which represent updated results from those presented to the US Food and Drug Administration, were published online July 19, 2010, ahead of print in Circulation.
In January 2010 the FDA approved the Melody valve (Medtronic, Minneapolis, MN) under the humanitarian device exemption (HDE) program. The device consists of a valved segment of bovine Plug Valves
jugular vein sewn within a balloon-expandable stent. Prior to the approval, open surgery was the only means of treating complications with RVOT conduits. Approximately 1,000 patients per year in the United States are anticipated to be eligible for implantation with the valve, according to the manufacturer.
For the expanded US Melody trial, researchers led by Julie A. Vincent, MD, of Children’s Hospital of New York (New York, NY), implanted the valve in 124 patients (median age of 19 years) with dysfunctional RVOT conduits at 5 US centers (adding 2 centers from the original study) from January 2007 through August 19, 2009. The primary indication for treatment was either pulmonary regurgitation, conduit obstruction, or a combination of the 2.
There was 1 death from intracranial hemorrhage after coronary artery dissection, and 1 valve was explanted after conduit rupture.
Short-term Results
In terms of immediate results, transcatheter pulmonary valve placementSafety valves
resulted in reduction of median right ventricular (RV) systolic pressure from 65.3 mm Hg to 41.5 mm Hg, and median peak RVOT pressure gradient from 37 mm Hg to 12 mm Hg. In addition, the ratio of RV to aortic pressure was reduced from a median of 0.74 to a median of 0.42. Although additional interventions at the same catheterization were not permitted in the initial 35 implanted patients, procedures were performed in 51 of the subsequent 89 patients who underwent valve implantation. These included bare-metal stenting of the RVOT (n = 43), as Gauge Valves
well as branch pulmonary artery stenting or angioplasty (n = 8), coronary artery stenting (n = 1), inferior vena cava stenting (n = 1), and atrial septal defect closure (n = 1). Average procedure and fluoroscopy times were 174 ± 67 and 46 ± 25 minutes, respectively.
Improvements in NYHA class were observed at 6-month follow-up and were sustained through 2 years in most patients (there were 5 patients who declined in NYHA class). At 6 months, echo and MRIFilters
testing showed positive results in patients with paired data in terms of RV pressure, mean RVOT gradient, and RV end diastolic volume, although RV ejection fraction did not change (table 1).
原文来自： http://www.shreveporttimes.com/article/20091205/NEWS01/91205007/1060
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以下是参考译文：
译文：2010年1月美国FDA批准的旋律阀设备启动
在一个正常的右心室流出道患者使用导管肺动脉瓣（右室流出道）管道化工泵
已经表现出了手术成功率很高，并鼓励短期的功能，尽管有人为支架骨折reinterventions关注。调查结果，代表更新从提交给美国食品和药物管理局的结果，是在网上公布2010年7月19日之前，流通打印。
在2010年1月美国FDA批准的旋律阀（美敦力公司，明尼阿波利斯，MN）的设备下的人道主义豁免（HDE）计划。该装置由内球囊扩张式支架的牛颈静脉带瓣缝合部分。在此之前批准，开放手术是治疗右室流出道导管并发症的唯一手段。每年大约有1000名患者在美国，预计将同阀植入资格，按照制造商。
为扩大美国旋律试验，研究人员领导的由朱莉答：文森特，医学博士，儿童的纽约（纽约州）医院，植入124例（平均年龄19岁阀）在美国与功能失调性右室流出道5管道中心（加2从原来的研究中心从2007年1月）通过2009年8月19日。为排污泵
治疗的主要适应症是不是肺返流，导管阻塞，或一对二的组合。
有一颅内出血死亡后冠状动脉夹层，1瓣管道破裂后，外植体。
短期结果
在当前结果来看，经导管肺动脉瓣膜放置在正中，导致右心室（房车减少）为65.3毫米汞柱收缩压为41.5毫米汞柱，并从37毫米汞柱右室流出道压力梯度峰值中位数为12毫米汞柱。此外，对房车的比例从主动脉压力下降了0.74中位数的0.42的真空泵
中位数。虽然在同一导管补充干预措施并没有在最初的35个植入患者允许的，程序是在随后进行的89例患者行瓣膜植入谁51。这些措施包括裸机的右室流出道（不适用支架= 43），以及肺动脉分支或支架成形术（8例），冠状动脉支架置入术（1例），下腔静脉支架置入术（1例），和房间隔缺损（1例）。平均程序和透视时间分别为174 ± 67和46 ± 25分钟分别。
在改善心功能类，观察6个月的后续行动并通过2年的大多数患者（有5例NYHA心功能分级油泵
谁在持续下降）。在6个月，回声和MRI检测显示，与右心室压力方面的配对数据，阳性结果意味着右室流出道坡度，和RV舒张末期容积，右室射血分数虽然没有改变（见表1）。
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